Introduction of Mycotic Prophylaxis At Cystectomy Trial.

NCT06770530 | Recruiting Phase 4

• 1 other identifier: 2023-506226-36-00
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to introduce a perioperative antifungal prophylaxis for patients undergoing cystectomy: surgically removal of the urinary bladder with construction of a urinary diversion. We wish to investigate the effect of antifungal prophylaxis on complications after the operation.

Conditions

Cystectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  Measured by Clavien Dindo III-V classification score. The Clavien Dindo Classification is used to rank the severity of a surgical complication. It consists of seven grades (I, II, IIIa, IIIb, IVa, IVb, V) with I being any deviation from the normal postoperative course and V being death of a patient.

  90 days from surgery

Secondary Outcomes (7)

• Days Alive and Out of Hospital (DAOH)

  90 days from surgery

• Time to gastrointestinal function

  Postoperatively within 90 days

• Nasogastric tube placement

  Postoperatively within 90 days

• Length of stay (LOS)

  90 days from surgery

• Readmission rate

  90 days after surgery

Study Arms (2)

Fluconazole

EXPERIMENTAL

Intravenous Fluconazole 400 mg single dose in 200 ml saline solution

Drug: Fluconazole

Isotonic saline solution

PLACEBO COMPARATOR

Intravenous saline solution single dose 200 ml

Drug: Isotonic saline solution

Interventions

Fluconazole DRUG

400 mg inravenous Fluconazole, single dose 200 ml

Fluconazole

Isotonic saline solution DRUG

Intravenous saline solution, single dose 200 ml

Isotonic saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years and older
• Willingness to participate in the study and the ability to understand and sign an informed consent
• Indication for performing cystectomy
• The urinary diversion is limited to the ileal conduit

You may not qualify if:

• Patients with contraindications to Fluconazole. This includes allergies and treatment with non-pausable medication that in combination is contraindicated
• Patients in active treatment for mycotic infections

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Urology, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (10)

• Maibom SL, Roder MA, Poulsen AM, Thind PO, Salling ML, Salling LN, Kehlet H, Brasso K, Joensen UN. Morbidity and Days Alive and Out of Hospital Within 90 Days Following Radical Cystectomy for Bladder Cancer. Eur Urol Open Sci. 2021 Apr 19;28:1-8. doi: 10.1016/j.euros.2021.03.010. eCollection 2021 Jun.

  PMID: 34337519 BACKGROUND

• Andrijasevic N, Ovcaricek S, Butic I, Navratil M, Mili B. Comparison of the effectiveness of two combinations of antibiotic used for perioperative prophylactic therapy during radical cystectomy: A retrospective cohort study. Can Urol Assoc J. 2022 Nov;16(11):E539-E544. doi: 10.5489/cuaj.7859.

  PMID: 35704932 BACKGROUND

• Lightner DJ, Wymer K, Sanchez J, Kavoussi L. Best Practice Statement on Urologic Procedures and Antimicrobial Prophylaxis. J Urol. 2020 Feb;203(2):351-356. doi: 10.1097/JU.0000000000000509. Epub 2019 Aug 23.

  PMID: 31441676 BACKGROUND

• Villmones HC, Halland A, Stenstad T, Ulvestad E, Weedon-Fekjaer H, Kommedal O. The cultivable microbiota of the human distal ileum. Clin Microbiol Infect. 2021 Jun;27(6):912.e7-912.e13. doi: 10.1016/j.cmi.2020.08.021. Epub 2020 Aug 21.

  PMID: 32835795 BACKGROUND

• Prunty M, Rhodes S, Rivero MJ, Callegari M, Jesse E, Arenas-Gallo C, Brant A, Calaway A, Scherr D, Shoag JE. National Adherence to Guidelines for Antimicrobial Prophylaxis for Patients Undergoing Radical Cystectomy. J Urol. 2023 Feb;209(2):329-336. doi: 10.1097/JU.0000000000003069. Epub 2022 Nov 16.

  PMID: 36383758 BACKGROUND

• Mitropoulos D, Artibani W, Graefen M, Remzi M, Roupret M, Truss M; European Association of Urology Guidelines Panel. Reporting and grading of complications after urologic surgical procedures: an ad hoc EAU guidelines panel assessment and recommendations. Eur Urol. 2012 Feb;61(2):341-9. doi: 10.1016/j.eururo.2011.10.033. Epub 2011 Oct 29.

  PMID: 22074761 BACKGROUND

• Maibom SL, Roder MA, Aasvang EK, Rohrsted M, Thind PO, Bagi P, Kistorp T, Poulsen AM, Salling LN, Kehlet H, Brasso K, Joensen UN. Open vs robot-assisted radical cystectomy (BORARC): a double-blinded, randomised feasibility study. BJU Int. 2022 Jul;130(1):102-113. doi: 10.1111/bju.15619. Epub 2021 Nov 9.

  PMID: 34657367 BACKGROUND

• Mitropoulos D, Artibani W, Biyani CS, Bjerggaard Jensen J, Roupret M, Truss M. Validation of the Clavien-Dindo Grading System in Urology by the European Association of Urology Guidelines Ad Hoc Panel. Eur Urol Focus. 2018 Jul;4(4):608-613. doi: 10.1016/j.euf.2017.02.014. Epub 2017 Mar 7.

  PMID: 28753862 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139-44. doi: 10.1200/JCO.1998.16.1.139.

  PMID: 9440735 BACKGROUND

MeSH Terms

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andreas Røder, MD, PhD, Professor

  Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Ulla N Joensen, MD, PhD

  Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mie Ynddal, MD

CONTACT

+4535456152; mie.skjoettgaard.ynddal@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: January 13, 2025
• Study Start: June 24, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 13, 2025

Record last verified: 2024-06

Locations

DK (1)